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Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension

Hyderabad, 04 December 2023: Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, for Sildenafil for Oral Suspension, 10 mg/mL. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for Oral Suspension, 10mg/ml, of Viatris Specialty LLC.

Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.

Granules now has a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 tentative approvals).

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million, according to MAT Sep 2023, IQVIA/IMS Health.

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